BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 7968787 · Received October 16, 2018

    Report

    Report Number
    1216677-2018-00060
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    August 20, 2018
    Report Date
    October 16, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Removal / Correction Number
    1216677-05-24-2019-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    *INVESTIGATION. X-REVIEW DHR . X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS SEVERAL BOARDS WERE REPLACED DUE TO BOARD FAILURES. REF WO'S 214148 & 195875. SERVICE & REPAIR CONFIRMED THE COMPLAINT CONDITION. SUSTAINING ENGINEERING HAD IDENTIFIED ONE ISSUE WITH A CAPACITOR THAT HAD THE POTENTIAL TO BE OVERLOADED DUE TO EXCESSIVE CURRENT ABOVE THE CAPACITORS' RATING. THE PART OF THE CIRCUIT THAT HAD BEEN FOUND TO HAVE AN ISSUE ON COMPLAINT AND IN PRODUCTION WAS C21 LOCATED ON THE DISPLAY BOARD. IT'S FAILURE AFFECTED THE FOOT PEDAL FUNCTION DUE TO BEING SHORTED. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO A BOARD UPDATE FROM NON-ROHS TO ROHS BOARDS. THE CHANGE HAD MADE THE C21 CAPACITOR PRONE TO EXCESSIVE CURRENT. THE BOARD USED IN THIS ASSEMBLY IS PRIOR TO THE BOARD BEING UPDATED TO INCLUDE A DIODE ON C21. THE DIODE PREVENTS EXCESSIVE CURRENT FROM SHORTING OUT THE COMPONENT. *CORRECTION AND/OR CORRECTIVE ACTION /*PREVENTATIVE ACTION ACTIVITY THE UNIT WAS FITTED WITH A BOARD THAT HAD BEEN UPDATED TO HAVE THE ZENER DIODE WHICH WAS PUT IN PLACE TO MITIGATE THE C21 COMPONENT FROM BEING OVERLOADED WITH CURRENT. ECN-21881 WAS EXECUTED TO UPDATE THE PRINT REFERENCING SUPPORTING ENG-TEST10487 & ENG-TEST-10504. REMAINING BOARDS IN STOCK WERE UPDATED TO INCLUDE THE DIODE UNDER WO #255846. CAPA 725 WAS ISSUED AND A RECALL (1216677-05-24-2019-002-R) WILL ADDRESS THE REMAINING UNITS FROM THE IMPLEMENTATION OF THE ROHS BOARD INTO PRODUCTION UP TO THE ADDITION OF THE ZENER DIODE.

    Description of Event or Problem · 0

    FOOT PEDAL IS ONLY INTERMITTENTLY WORKING CURRENT IS COMING ON AND OFF BY ITSELF.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT IS EXPECTED TO BE RETURNED FOR EVALUATION BY CUSTOMER. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PEN STOPPED WORKING DURING PROCEDURE TWICE. HAVE HAD ISSUES WITH COAG AND CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809446 LEEP PRECISION GENERATOR LEEP PRECISION GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other